510(k) · Cleared
Recalled · Class II · 2022iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 12, 2021 as substantially equivalent to K203447 (Conformis, Inc., 2020) and 1 other predicate after a 56-day review. Its family tree reaches back 19 generations to 1981. 4 later devices descend from it. It has been recalled once.
- Decided
- May 12, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 19 generations to K810258 (1981). 179 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 15 generations between
- 3 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 2 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- 1 generation backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- This deviceK210809 iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK230846 iTotal Identity Knee Replacement System; Identity Imprint Knee…Conformis, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243768 iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement…Restor3D, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK232426 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement…Conformis, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 18 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 17 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 16 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 15 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 14 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 13 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 12 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 11 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 10 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 9 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 8 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 7 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 6 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 5 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 4 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- 3 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 2 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- 1 generation backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- This deviceK210809 iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023 · cites it directly2descendants
- K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc. · 2023 · cites it directly1descendant
- K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc. · 2025 · 2 generations on0descendants
- K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −18 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −17 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −16 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −15 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −14 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −13 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −12 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −11 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −10 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −9 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −8 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −7 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −6 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate… | Conformis, Inc. | 2016 | 1 |
| −5 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | — |
| −4 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 4 |
| −3 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| −2 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| −1 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| 0 (this device) | K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | 2021 | — |
| +1 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement… | Conformis, Inc. | 2023 | — |
| +1 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with… | Conformis, Inc. | 2023 | — |
| +2 | K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025 | — |
| +2 | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)… | Conformis, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Summary page 4…iTotal® Identity™ Posterior Sacrificing (PS) Knee Replacement System Primary Predicate Device 510(k): K203447, December 22, 2020 52… | 2020 |
| * | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity…Summary page 5…iTotal® Identity™ Posterior Stabilized (PS) Knee Replacement System Secondary Predicate Device 510(k): K210252, February 18, 2021 Secondary Predicate Device JWH, OOG, OIY Product Classification Code(s) and Knee joint patellofe… | 2021 |
| † | K173849 | Triathlon Total Knee System | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2022 | Class II | Z-0899-2022 | Nonconforming Material/Component | Incorrect tibial base plate implant packaged in kit |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 83 of the 179 ancestors have a recall of any class.
- Of its descendants, K230846 (Conformis, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K203447.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: * Painful joint disease due to osteoarthritis…
Read the full statement (159 words)
The iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
* Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
* Post traumatic loss of joint function.
* Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
* Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
* Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only. The CS insert option should be utilized when additional anterior-posterior constraint is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210809 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210809: iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210809
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026